BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON ET TUBE, HVT, 6.0

    MDR report key: 7621785 · Received June 20, 2018

    Report

    Report Number
    3003898360-2018-00451
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 6, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K822082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE UNIT 5-103126 ET TUBE, HVT, 6.0 FOR INVESTIGATION. THE ET TUBE WAS RETURNED WITH A PILOT BALLOON FROM A RUSCH ET TUBE THAT DID NOT BELONG TO THE DEVICE. THE RETURNED ET TUBE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED ET TUBE REVEALED THAT THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. THE CONNECTOR WAS NOT RETURNED. THE CONNECTOR IS ORIGINALLY SEATED LOOSELY IN THE TUBE AND NOT SEATING THE CONNECTOR FIRMLY INTO THE TUBE BEFORE USE CAN CAUSE IT TO DISCONNECT. IT COULD NOT BE CONFIRMED IF THE CONNECTOR WAS PUSHED FIRMLY INTO THE TUBE OR NOT. THE IFU FOR THIS PRODUCT STATES, "THE 15 MM CONNECTOR MAY BE LOOSELY SEATED DUE TO THE RELAXATION OF THE TUBE MATERIAL AROUND THE CONNECTOR. SEAT THE CONNECTOR FIRMLY IN THE TRACHEAL TUBE. FOR A SECURE CONNECTION, THE CONTACTING SURFACES MUST BE CLEAN AND DRY WHEN SEATING THE CONNECTOR." "SEAT THE 15 MM CONNECTOR FIRMLY IN THE ADAPTER ON THE VENTILATOR EQUIPMENT TO PREVENT DISCONNECTION DURING USE. ORDINARILY THE SECURITY OF THE CONNECTION IS INCREASED BY TWISTING THE TWO ELEMENTS TOGETHER." "NON-STANDARD DIMENSIONS OF SOME CONNECTORS ON VENTILATOR OR ANESTHESIA EQUIPMENT MAY MAKE IT DIFFICULT TO SECURELY MATE WITH THE TRACHEAL TUBE 15 MM CONNECTOR. USE ONLY THE EQUIPMENT HAVING 15 MM CONNECTORS THAT ARE STANDARD IN COMPLIANCE WITH (B)(4)". THE REPORTED COMPLAINT OF "HUB DISCONNECTS DURING USE" COULD NOT BE CONFIRMED. HOWEVER, FURTHER TESTING IS ONGOING AT THE MANUFACTURING SITE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. IF THE CONNECTOR IS NOT SEATED FIRMLY INTO THE TUBE, THE CONNECTOR COULD DISCONNECT FROM THE TUBE DURING USE. HOWEVER, THE CONNECTOR WAS NOT RETURNED AND IT COULD NOT BE DETERMINED IF THE CONNECTOR WAS SEATED FIRMLY INTO THE TUBE OR NOT DURING USE. A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE DEVICE "HUB CONTINUOUSLY SLIPS OUT OF THE ETT. THIS DISCONNECTS THE PATIENT FROM THE VENTILATOR AND WITH SUCH A SMALL ETT HIS AIRWAY IS COMPROMISED. DUE TO AIRWAY SWELLING WE ARE UNABLE TO RE-INTUBATE THE PATIENT. THE HUB HAS BEEN REPLACED, REINSERTED AND SECURED NUMEROUS TIMES OVER THE WEEKEND". THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION RELATED TO THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE DEVICE "HUB CONTINUOUSLY SLIPS OUT OF THE ETT. THIS DISCONNECTS THE PATIENT FROM THE VENTILATOR AND WITH SUCH A SMALL ETT HIS AIRWAY IS COMPROMISED. DUE TO AIRWAY SWELLING WE ARE UNABLE TO RE-INTUBATE THE PATIENT. THE HUB HAS BEEN REPLACED, REINSERTED AND SECURED NUMEROUS TIMES OVER THE WEEKEND". THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION RELATED TO THE ALLEGED MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AT THE TIME OF THIS REPORT. DEVICE MATERIAL NUMBER REPORTED IS NOT BEING MANUFACTURED CURRENTLY. HOWEVER, A DEVICE FROM THE SAME FAMILY WAS USED FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS". SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION AND WERE VISUALLY INSPECTED. THE ISSUE REPORTED WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A RECORD ASSESSMENT (FMEA) WAS CONDUCTED AND NO UPDATE IS REQUIRED. IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION TO CONFIRM THE ALLEGED DEFECT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED AT THIS TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE DEVICE "HUB CONTINUOUSLY SLIPS OUT OF THE ETT. THIS DISCONNECTS THE PATIENT FROM THE VENTILATOR AND WITH SUCH A SMALL ETT HIS AIRWAY IS COMPROMISED. DUE TO AIRWAY SWELLING WE ARE UNABLE TO RE-INTUBATE THE PATIENT. THE HUB HAS BEEN REPLACED, REINSERTED AND SECURED NUMEROUS TIMES OVER THE WEEKEND".THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION RELATED TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462486 HUDSON ET TUBE, HVT, 6.0 TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R